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A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis

Primary Purpose

Chronic Erosive Gastritis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Teprenone capsule and placebo of sucralfate
Sucralfate and placebo of teprenone
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Erosive Gastritis focused on measuring Chronic Erosive Gastritis, Teprenone, Sucralfate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-65 years old
  2. Have been diagnosed as chronic non-atrophic erosive gastritis by endoscopy within 1 weeks before enrollment, and the modified Lanza score ≥ 2
  3. Have at least two symptoms in four major symptoms (epigastric pain, epigastric burning, early satiety, belching) and total symptom score ≥ 4 (Rome Ⅲ for Functional Gastrointestinal Disorders)

Exclusion Criteria:

  1. Suspected upper gastrointestinal malignancy by endoscopy
  2. Peptic ulcer and bleeding by endoscopy
  3. Severe cardiac, hepatic or renal insufficiency
  4. Severe neurological or psychological disease
  5. Pregnant or lactating women
  6. Have taken drugs which may affect evaluating the efficacy of study drug within two weeks before enrollment (includes but not limits to: Proton pump inhibitors such as omeprazole, rabeprazole, pantoprazole, lansoprazole, esomeprazole, H2 receptor antagonists such as cimetidine, ranitidine, famotidine, antacids such as calcium carbonate, gastric mucosal protectants such as colloidal bismuth potassium citrate and other bismuth products, sucralfate, aluminum phosphate, teprenone, gefarnate, aluminum magnesium carbonate, glutamine, rebamipide, ecabet, misoprostol, antibiotics such as amoxicillin, clarithromycin, tetracycline, ofloxacin, levofloxacin, furazolidone, metronidazole, tinidazole, Non-Steroid Anti-Inflammatory Drugs such as aspirin, ibuprofen, loxoprofen, naproxen, diclofenac, indomethacin, meloxicam, acetaminophen)
  7. History of allergic reaction to the medications used in this study
  8. Patients that investigators consider ineligible for this study

Sites / Locations

  • Tongren Hospital
  • Zhongshan Hospital of Xiamen University
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Dalian Medical University
  • Changhai Hospital
  • Shanghai Xinhua Hospital
  • First Affiliated Hospital of Shanxi Medical University
  • General Hospital of Tianjin Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teprenone capsule

sucralfate

Arm Description

Outcomes

Primary Outcome Measures

The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group

Secondary Outcome Measures

The difference of total effective rate after 4 weeks treatment evaluated by histologic examination on inflammation improvement between teprenone group and sucralfate group
The difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 weeks treatment between teprenone group and sucralfate group
The difference of total effective rate after 4 and 8 weeks treatment evaluated by clinical symptom score between teprenone group and sucralfate group
The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group

Full Information

First Posted
January 26, 2011
Last Updated
January 13, 2014
Sponsor
Changhai Hospital
Collaborators
Eisai China Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01284647
Brief Title
A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis
Official Title
A Prospective, Randomized, Double-blind, Double-dummy, Sucralfate Controlled, Multicenter Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
Eisai China Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Erosive Gastritis
Keywords
Chronic Erosive Gastritis, Teprenone, Sucralfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teprenone capsule
Arm Type
Experimental
Arm Title
sucralfate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Teprenone capsule and placebo of sucralfate
Intervention Description
Teprenone 1 capsule (50mg)+placebo of sucralfate 4tab, tid×8 weeks.
Intervention Type
Drug
Intervention Name(s)
Sucralfate and placebo of teprenone
Intervention Description
Placebo of teprenone 1 capsule+ sucralfate 4 tab(1.0), tid×8 weeks
Primary Outcome Measure Information:
Title
The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group
Time Frame
0,4 weeks
Secondary Outcome Measure Information:
Title
The difference of total effective rate after 4 weeks treatment evaluated by histologic examination on inflammation improvement between teprenone group and sucralfate group
Time Frame
4 weeks
Title
The difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 weeks treatment between teprenone group and sucralfate group
Time Frame
4 weeks
Title
The difference of total effective rate after 4 and 8 weeks treatment evaluated by clinical symptom score between teprenone group and sucralfate group
Time Frame
4 and 8 weeks
Title
The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years old Have been diagnosed as chronic non-atrophic erosive gastritis by endoscopy within 1 weeks before enrollment, and the modified Lanza score ≥ 2 Have at least two symptoms in four major symptoms (epigastric pain, epigastric burning, early satiety, belching) and total symptom score ≥ 4 (Rome Ⅲ for Functional Gastrointestinal Disorders) Exclusion Criteria: Suspected upper gastrointestinal malignancy by endoscopy Peptic ulcer and bleeding by endoscopy Severe cardiac, hepatic or renal insufficiency Severe neurological or psychological disease Pregnant or lactating women Have taken drugs which may affect evaluating the efficacy of study drug within two weeks before enrollment (includes but not limits to: Proton pump inhibitors such as omeprazole, rabeprazole, pantoprazole, lansoprazole, esomeprazole, H2 receptor antagonists such as cimetidine, ranitidine, famotidine, antacids such as calcium carbonate, gastric mucosal protectants such as colloidal bismuth potassium citrate and other bismuth products, sucralfate, aluminum phosphate, teprenone, gefarnate, aluminum magnesium carbonate, glutamine, rebamipide, ecabet, misoprostol, antibiotics such as amoxicillin, clarithromycin, tetracycline, ofloxacin, levofloxacin, furazolidone, metronidazole, tinidazole, Non-Steroid Anti-Inflammatory Drugs such as aspirin, ibuprofen, loxoprofen, naproxen, diclofenac, indomethacin, meloxicam, acetaminophen) History of allergic reaction to the medications used in this study Patients that investigators consider ineligible for this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongren Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Zhongshan Hospital of Xiamen University
City
Xiamen
State/Province
Guangdong
Country
China
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Xinhua Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
First Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

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A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis

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